DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
2. Claims 21, 22, 24-28 and 30 are pending.
3. Claims 21, 22, 24-28 and 30 are examined.
4. The objection to the specification is withdrawn in view of Applicant’s amendment to the disclosure.
5. The rejection under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendments to the claims.
6. The rejection under 35 U.S.C. 102(a)(1) is withdrawn in view of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(a)
7. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
8. Claims 21, 22, 24-28 and 30 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of making a transgenic maize plant comprising the full-length SEQ ID NO: 10, which represents the full-length nucleotide sequence of maize event MON 87419, does not reasonably provide enablement for the method as broadly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
This rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s arguments submitted on June 26, 2026 were fully considered but they are not persuasive.
In re Wands, 858 F.2d 731 (Fed. Cir. 1988) lists the following eight factors for determining whether undue experimentation would be required to practice an invention: (1) quantity of experimentation necessary; (2) amount of direction or guidance supplied; (3) presence or absence of working examples; (4) nature of the invention; (5) state of the prior art; (6) relative skill of those in the art; (7) predictability or unpredictability or the prior art; (8) breadth of the claims.
Applicant claims a method for producing a maize plant that tolerates application of glufosinate and dicamba herbicides, comprising providing a DNA construct comprising a transgene insert, wherein the insert comprises, from the 5' to 3' orientation: (i) a promoter, leader, and intron of a ubiquitin gene from Andropogon gerardii operably linked to the pat gene from Streptomyces viridochromogenes operably linked to the polyadenylation signal of a RA5B precursor gene of Oryza sativa, and (ii) a promoter of Peanut Chlorotic Streak Virus with a duplicated enhancer region operably linked to a leader of the light harvesting complex b1 gene from Triticum aestivum operably linked to a first intron from the actin 1 gene from Oryza sativa operably linked to the N-terminal chloroplast transit peptide from the Petunia hybrida 5-enolpyruvylshikimate-3-phosphate synthase gene operably linked to the dmo gene from Stenotrophomonas maltophilia optimized for monocot expression operably linked; to the heat shock protein 17 polyadenylation signal from Triticum aestivum. Applicant claims said method further comprising introducing the DNA construct into a maize plant cell; regenerating the maize plant cell to produce a maize plant; and selecting the maize plant for comprising a recombinant DNA molecule selected from SEQ ID NO:1-8 and 10 as part of its genome, wherein the maize such that the plant tolerates application of glufosinate and dicamba herbicides.
Applicant teaches making plants of maize event MON 87419 by transforming maize embryos with a vector comprising an expression cassette that confers tolerance to dicamba, and another vector comprising an expression cassette that confers tolerance to glufosinate; and subsequently selecting for tolerance to said herbicides as well as desired agronomic characteristics (Example 1). Applicant teaches sequencing the 5’ and 3’ junction regions of the event, including the surrounding native genomic sequences (page 32 paragraph 0085).
Applicant teaches that SEQ ID NO: 10 represents the full-length sequence of the event, which comprises the sequence of the transgene, as it is incorporated in the maize genome, as well as the flanking genomic regions. Applicant teaches that SEQ ID NO: 9 is the sequence of the transgene insert of the maize MON 87419 event. Applicant teaches that SEQ ID NO: 1-8 are nucleic acid sequences that range in length from 30 nucleotides to 1771 and encompass the 5’ and 3’ junctions between the event and the maize genome, and comprise both, nucleotides from the transgene and the genome. Applicant teaches that SEQ ID NO: 14-22 are polynucleotides “corresponding to unique sequences within the transgenic insert” of the event (see Brief Description of the Sequences on pages 6-7 of the specification).
Applicant does not teach how to predictably use the invention through the full scope of the claims. Applicant does not teach how to practice the claimed method to use a plant other than the plant of the event. Both the specification and the state of the prior art indicate that it would be highly unpredictable to attempt to practice the invention through the full scope of the claims.
The specification teaches that SEQ ID NO: 9 is the transgene part of maize event MON 87149, where the configuration of the elements of SEQ ID NO: 9 itself and of the insert relative to the surrounding maize genome is unpredictable. Applicant teaches that obtaining the event involved “the production and analysis of tens of thousands of individual plants over multiple years” (page 19). Applicant teaches that in order to obtain the transformants used to select the event, two vectors were introduced into maize plants - one comprising the pat gene, the other one - the dmo gene (Example 1, page 19). Thirteen thousand transformants were produced, from which the single maize event was selected after extensive molecular and phenotypic screening (Example 1; pages 20-21; Tables 1 and 2). The nucleotide sequence of the event, SEQ ID NO: 10, which encompasses SEQ ID NO: 9 resulted from the incorporation of the elements of said two vectors at an unpredictable site of the genome of the maize plant and in an unpredictable configuration. The specification teaches that “The expression of foreign genes in plants is known to be influenced, among other things, by their chromosomal position. For this reason, it was necessary to screen a large number of individual plants containing random insertion events through multiple years and locations to identify the optimal event” (page 20).
If one were to attempt to practice the above methods steps using a DNA construct comprising the elements functionally recited in claim 21, in view of the teachings of the specification, one would need to perform the screening and analysis similar to the one that Applicant performed in order to arrive at event MON 87419. Doing so would amount to undue trial and error experimentation.
Claim 21, as instantly amended, recites selecting maize plant comprising any one of SEQ ID NO: 1-8 or 10, wherein the plant tolerates application of dicamba or glufosinate. However, SEQ ID NO’s 1-4 are 30- and 60-mers that encompass the 3’ or the 5’ junction of the event. Their expression will not confer tolerance to dicamba or glufosinate. The same reasoning applies to SEQ ID NO: 5-6 that are only 100 nucleotides long.
The claims also encompass a method wherein the introduction of SEQ ID NO: 9 into the genome of a maize plant results in a configuration similar to that which is present in the full-length event MON 87419. Applicant has not taught how to practice said method short of repeating the transformation and screening of thousands of plants or using the plants of event MON 87419 themselves.
The unpredictability of being able to use the genus of plants encompassed by the claims is borne out by the state of the prior art. For example, Devine teaches that the development of a transgenic event with acceptable properties is much more complex than merely obtaining a transformant, and involves the screening of a large population of transgenic plants to eliminate those that do not meet the molecular requirements (Pest Manag. Sci. (2005) 61:312-317; pg. 314, right col. - pg. 315 left col).
Thus, given limited guidance supplied by Applicant, the breadth of the claims and the nature of the invention, it would have required one skilled in the art undue trial and error experimentation to practice the claimed invention through the full scope of its claims.
Response to Arguments
Applicant argues that the claims have been amended. Applicant argues that “The amended claims do not require discovering a new event but recite a defined DNA construct with specific, known genetic elements and selecting the resulting plant for comprising specific diagnostic DNA sequences. One of ordinary skill, armed with the complete sequence information and the deposited seed (ATCC Accession No. PTA-120860), could use established transformation and selection techniques to produce the claimed maize plant.” (pages 6-7 of the Remarks).
Applicant argues that the teachings of Devine are materially different from the instant scenario because “the transgene insert has already been fully characterized and sequenced” (page 8 of the Remarks).
Applicant’s argument is not found to be persuasive. Applicant’s amendments are acknowledged but they are not sufficient to overcome the rejection.
Applicant’s argument is not commensurate with the scope of the claims. The claims encompass the method of making a maize plant using any of the functionally-recited transgenic elements (no structure is supplied in part (a) of claim 21), wherein the resultant plant comprises any one of SEQ ID NO: 1-8 or 10 and is tolerant to dicamba or glufosinate. It is not in dispute that Applicant did teach how to use said method to arrive at the plant of transgenic event MON 87419. However, Applicant has not taught using the steps of the method, as broadly claimed.
The fact that the sequences of said event were identified, as Applicant argues, does not help resolve the enablement issue. This is because the genomic incorporation site (as well as the transgene configuration) of the event itself is unpredictable, and, as admitted in the specification, the process of obtaining the event involved “the production and analysis of tens of thousands of individual plants over multiple years” (emphasis supplied). While there is no dispute that Applicant did successfully obtain the plants of event MON 87419, using said years-long production and analysis, even attempting to reproduce the event using the steps of claim 21 would be unpredictable, precisely because of the unique and random nature of the integration site and the extensive experimentation that was required to obtain the event in the first place.
Attempting to use the claims method to make other plants having dicamba and glufosinate tolerance and comprising the recited sequences would have been similarly unpredictable. For example, SEQ ID NO: 1-4 are short sequences comprising the 3’ or 5’ junctions between the transgenic insert of event MON 87419 and the surrounding maize genomic DNA. One would not have been able to predictably obtain a maize plant comprising any of those, even if a DNA transformation construct used the same elements as the elements in the plasmid used to obtain event MON 87419. It is noted that Applicant has not reduced to practice any maize plants comprising any one of SEQ ID NO: 1-10 and having tolerance to dicamba and/or glufosinate other than the plants of maize event MON 87419.
The argument directed to the teachings of Devine is not found to be persuasive either. Devine’s teachings regarding the development of transgenic events not only illustrate the state of the art, but is fully consistent with both, the teachings of the specificaiton, and the Examiner’s position regarding the lack of predictability if one were to attempt to practice the claimed method through its full scope. Specifically, Devine teaches that the development of a transgenic event with acceptable properties is much more complex than merely obtaining a transformant, and involves screening of a large population of transgenic plants to eliminate those that do not meet the molecular requirements. In the context of the instant claims, the screening to which Devine refers would require expensive and undue trial and error experimentation. The rejection is maintained.
Conclusion
9. No claims are allowed.
10. The claims are deemed free from the prior art. The closest prior art is Fabbri et al (US Patent Publication 2008/0256669), which teaches making a corn plant comprising a pat and a dmo transgenes that confer tolerance to glufosinate and dicamba, but does not teach a method of using the instantly claimed “transgenic insert” (claims 1-3 of Fabbri eta al).
11. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRATISLAV STANKOVIC can be reached at (571)270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662
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